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Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

Primary Purpose

Knee Injuries

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
Institut d'Investigacions Biomèdiques August Pi i Sunyer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring virtual reality, embodiment, rehabilitation, anterior cruciate ligament reconstruction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-40 (either sex)
  • Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft

Exclusion Criteria:

  • Patients with significant cognitive deficit (MEC<24).
  • Patients with epilepsy or severe vision problems
  • Pregnant patients
  • Previous surgery on the reconstructed knee, excluding arthroscopy
  • Previous anterior cruciate ligament reconstruction on either knee
  • Sustained concurrent injury to the contralateral knee
  • Concomitant collateral ligament and/or meniscal repair
  • Presence of symptomatic tibiofemoral osteoarthritis

Sites / Locations

  • IDIBAPSRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality

Standard intervention

Arm Description

Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol

Standard rehabilitation protocol only

Outcomes

Primary Outcome Measures

The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

Secondary Outcome Measures

Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Isometric quadriceps strength
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Knee extension active range of motion
Measured with a digital goniometer (smartphone app)
Time taken to return to sporting activity
Taken retrospectively at 9 months, number of days from surgery to full return to sport

Full Information

First Posted
September 20, 2021
Last Updated
October 4, 2021
Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborators
Fundación Mutua Madrileña
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1. Study Identification

Unique Protocol Identification Number
NCT05080894
Brief Title
Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction
Official Title
Early Domestic Rehabilitation Using Virtual Reality for Patients With Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
March 15, 2023 (Anticipated)
Study Completion Date
March 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Collaborators
Fundación Mutua Madrileña

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to ascertain whether 4 weeks of daily virtual-reality-based rehabilitation at home improves disability in the early stages of recovery from anterior cruciate ligament reconstruction surgery compared with standard care.
Detailed Description
After being informed about the study and potential risks and benefits, patients giving written informed consent will be randomized to one of two groups in a 1:1 ratio. The treatment group will perform daily a 20-minute rehabilitation session in virtual reality, in which they will observe their virtual body performing a series of exercises they would otherwise be unable to perform in real life. Both groups will also undergo the standard rehabilitation protocol. The investigators will assess for differences between groups in self-reported disability, knee range of motion, and quadriceps strength at baseline, 4 weeks, 12 weeks and 9 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
virtual reality, embodiment, rehabilitation, anterior cruciate ligament reconstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality
Arm Type
Experimental
Arm Description
Daily 20-minute sessions of virtual reality based rehabilitation for the first 4 weeks post-operatively + standard rehabilitation protocol
Arm Title
Standard intervention
Arm Type
No Intervention
Arm Description
Standard rehabilitation protocol only
Intervention Type
Device
Intervention Name(s)
Virtual reality
Intervention Description
Embodiment of a healthy virtual body in virtual reality and action observation/motor imagery of the subject's virtual body performing high-level lower limb exercises.
Primary Outcome Measure Information:
Title
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Description
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time Frame
Baseline (day 1 post-surgery)
Title
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Description
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time Frame
4 weeks
Title
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Description
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time Frame
12 weeks
Title
The International Knee Documentation Committee (IKDC) Subjective Knee Form
Description
Patient-completed tool, which contains sections on knee symptoms/pain, function, and sports activities. Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Isometric quadriceps strength
Description
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time Frame
Baseline
Title
Isometric quadriceps strength
Description
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time Frame
4 weeks
Title
Isometric quadriceps strength
Description
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time Frame
12 weeks
Title
Isometric quadriceps strength
Description
Measured knee extension strength with a handheld dynamometer, expressed as peak force (Newtons)
Time Frame
9 months
Title
Knee extension active range of motion
Description
Measured with a digital goniometer (smartphone app)
Time Frame
Baseline
Title
Knee extension active range of motion
Description
Measured with a digital goniometer (smartphone app)
Time Frame
4 weeks
Title
Knee extension active range of motion
Description
Measured with a digital goniometer (smartphone app)
Time Frame
12 weeks
Title
Knee extension active range of motion
Description
Measured with a digital goniometer (smartphone app)
Time Frame
9 months
Title
Time taken to return to sporting activity
Description
Taken retrospectively at 9 months, number of days from surgery to full return to sport
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-40 (either sex) Post-operative anterior cruciate ligament reconstruction (autograft), either bone-patellar tendon-bone graft or semitendinosus (hamstring) graft Exclusion Criteria: Patients with significant cognitive deficit (MEC<24). Patients with epilepsy or severe vision problems Pregnant patients Previous surgery on the reconstructed knee, excluding arthroscopy Previous anterior cruciate ligament reconstruction on either knee Sustained concurrent injury to the contralateral knee Concomitant collateral ligament and/or meniscal repair Presence of symptomatic tibiofemoral osteoarthritis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria V. Sanchez-Vives, PhD
Phone
93 227 5400
Ext
4379/4302
Email
msanche3@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Tony G Donegan, MSc
Phone
93 227 5400
Ext
4379/4302
Email
donegan@clinic.cat
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria V. Sanchez-Vives
Organizational Affiliation
Institut d'Investigacions Biomèdiques August Pi i Sunyer
Official's Role
Principal Investigator
Facility Information:
Facility Name
IDIBAPS
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria V Sanchez-Vives
Phone
93 227 5400
Ext
4302
Email
msanche3@clinic.cat

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Virtual Reality Rehabilitation for Patients With Anterior Cruciate Ligament Reconstruction

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